Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Co
FDA device recall Z-0399-2007 · posted 2007-02-08 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
- Action taken
- Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 23 units
- Distribution
- Nationwide and Canada.
- Date initiated
- 2006-12-04
- Date posted
- 2007-02-08
- Date terminated
- 2007-02-21
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIATHLON KNEE SYSTEM (K051146) | Howmedica Osteonics Corp. | 2005-07-13 |